Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease

June 14, 2016 updated by: Biogen

A Phase II, Multi-Center, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Efficacy of Intravenous Antegren (Natalizumab) in Crohn's Disease Subjects Concurrently Receiving Remicade (Infliximab) and Not in Remission

The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.

Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-351.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32605
        • Digestive Disease Associates
      • Jacksonville, Florida, United States, 32223
        • Borland Groover Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Montana
      • Butte, Montana, United States, 59701
        • Mercury Street Medical
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates, LLP
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
      • Rocky Mount, North Carolina, United States, 27804
        • Boice-Willis Clinic
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Columbia Gastroenterology Associates
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Memphis Gastroenterology Group
      • Memphis, Tennessee, United States, 38120
        • Gastroenterology Center Of The Midsouth
    • Texas
      • Austin, Texas, United States, 78745
        • Austin Gastroenterology
    • Virginia
      • Danville, Virginia, United States, 24541
        • Internal Medicine Associates
      • Virginia Beach, Virginia, United States, 23455
        • Gastroenterology Consultants
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
      • Tacoma, Washington, United States, 98405
        • Digestive Health Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Male and female patients at least 18 years of age with at least a six-month history of Crohn's disease and who are currently receiving Remicade and are not in remission (CDAI greater than/equal to 150)
  • Women must not be breastfeeding or pregnant, and must not become pregnant during the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Elan Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (ACTUAL)

July 1, 2003

Study Completion (ACTUAL)

July 1, 2003

Study Registration Dates

First Submitted

March 4, 2003

First Submitted That Met QC Criteria

March 5, 2003

First Posted (ESTIMATE)

March 6, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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